Consumables, Paints, End-covers, NDE Chemicals & Tools suppliers classification and evaluation

#1
We are manufacturing API 6A, 16C and 17D monogram products. During the last surveillence audit, the auditor asked for the list of approved suppliers for Grease, Wooden packing material (boxes) and NDE Chemicals (LPT Dye Penetrant and Developer). He also asked for their latest evaluation/re-evaluation records.

We are procuring these items in common (Not specific for API products), hence we didn't have an approved supplier list, as we procure the above items from the open market (through tendering route). We managed to show the auditor the acceptance/testing reports of the above items and called it an assessment as per clause API Spec. Q1 9th ed. Add.2, Errata 3, 5.6.1.3 c) -assessment of the product or component upon delivery.

Can we follow the same approach for the forthcoming audits or do we need to have a better approach? Awaiting expert opinions on the matter.
 
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Thee Bouyyy

Multiple Personalities
#2
No, you can't. It will create trouble for you. Because on one side you are following the API Q1 5.6.1.3 c) than those vendors must be in your approved vendor list. To avoid this scenario, I would suggest you to write down this in your procedure for purchasing control (API Q1 5.6.1).

Something like this, "Items such as Grease, Wooden packing materials (boxes) and NDE chemicals (Penetrant and Developer) which is purchased for non API products will not be part of QMS system. For sake of clarity these items are procured from the open market through tendering route". Auditor won't question you further.

Few years back we received the non-conformance in similar clause for cotton waste, consumables and capital machinery related items. We simply added in the procedure and API accepted it and after that so many audits we faced with similar approach.

This is what we have added in our procedure for purchasing control.

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#3
This is what we have added in our procedure for purchasing control.

View attachment 28315
With respect to cotton waste and capital machinery, I am getting the point. Whereas for consumables say Grease & Paint, which goes along with the product and which might potentially affect the functioning of the product, can we consider them as common supplies outside the scope of API QMS ?Don't we need to classify them as critical or non-critical purchases and evaluate the respective suppliers accordingly?
 

Thee Bouyyy

Multiple Personalities
#4
Depends what you have defined in your QMS about the critical and non-critical suppliers.

Whereas for consumables say Grease & Paint, which goes along with the product and which might potentially affect the functioning of the product, can we consider them as common supplies outside the scope of API QMS ?Don't we need to classify them as critical or non-critical purchases and evaluate the respective suppliers accordingly?
Yes, you have to classify them as critical or non-critical and need to evaluate the supplier with respect to clause 5.6.1.2, 5.6.1.3 and 5.6.1.4.
 
#5
Hi, Santhsh,I agree with Thee. The VAL for non API monogram products does not belong to the scope of API Spec Q1, but the company still needs to manage it from the company management system. Sometimes API also asks the auditor to review the non API monogram products in your audit plan.
 
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